Self-Management Assistance for Recommended Treatment (SMART) Portal (SMART)

The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease; Indeterminate Colitis

Detailed Description

The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • BeHealth Solutions, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.

Description

Inclusion Criteria:

• Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively known as IBD)
• Patient between 11 and 18 years of age
• Patient prescribed at least one oral medication used to treat IBD
• Access to the internet whether public (example, library) or private (example, home, personal)
• English fluency for patient, caregiver, and clinician/nurse
• Clinician/nurse currently providing medical treatment to patients diagnosed with IBD through the IBD Center at Cincinnati Children's Hospital Medical Center

Exclusion Criteria:

• Diagnosis of pervasive developmental disorder in patient or caregiver
• Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Clinicians/Nurses; Clinicians and nurses who treat patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.
Patients; Patients age 11-18 years diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.
Caregivers; Caregivers of patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Medication adherence will be measured by pill count data provided by patients or caregivers at baseline and post-treatment during Phase 3. Phase 3 will start approximately in October 2014 and continue through March 2015.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease severity	Disease severity will be measured at baseline, post-treatment, and periodically throughout the intervention as the patient logs in to view intervention materials during Phase 3. The portal will prompt the patient to complete disease severity questions throughout the intervention, but it will be dependent upon the patient actually logging into the system. Therefore, exact time points during treatment are unknown. The Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to measure disease severity for patients diagnosed with ulcerative colitis and indeterminate colitis, and the Partial Harvey Bradshaw (PHBI) will be used for patients diagnosed with Crohn's disease. Phase 3 will start approximately in October 2014 and continue through March 2015.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Health-related quality of life	The IMPACT-III will be used during baseline and post-treatment in Phase 3 to measure quality of life in patients. Phase 3 will start approximately in October 2014 and continue through March 2015.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Lee Denson, M.D., Children's Hospital Medical Center, Cincinnati; Study Chair: James Peugh, Ph.D., Children's Hospital Medical Center, Cincinnati; Study Chair: Korey Hood, Ph.D., University of California, San Francisco; Study Chair: Lee Ritterband, Ph.D., BeHealth Solutions, LLC.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis
• Other Study ID Numbers: SMART